Tunisia Biosimilar Presentation
Tunisia Biosimilar Presentation
Tunisia Biosimilar Presentation
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Problem context
National level
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Problem context
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DRUG REGISTRATION IN
TUNISIA
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Marketing authorization procedure
UPM (MoH)
Application submission
Administrative information
(Module 1)
NMCL Experts
(Module 3) (Module 4 and 5)
Specialized Scientific
Assessment and Testing Commission (SSC)
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Security and efficacy assessment
(Module 4 and 5)
Global evaluation
• Quality report (NMCL)
Approval or rejection
• SSC opinion
of the MAA
• Price negotiation
REGISTRATION OF
BIOSIMILARS IN TUNISIA
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In case of a biosimilar , we are applying the procedure, following :
WHO
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FDA
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EMA
Guideline on similar biological medicinal products
CHMP/437/04 Rev 1
Heparin
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Filgrastim (Timeframes of MA)
INN Trade Name MAH MAA MA
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NB: All the pending MAA are published in our website : www.dpm.tn
Erythropoïetin
INN Trade Name MAH MAA MA
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Somatropin
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Gonadotrophin
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Enoxaparin
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Interferon beta 1a
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Insulin glargin
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Monoclonal antibodies
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TUNISIAN GUIDELINES FOR
BIOSIMILARS
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Tunisian Guidelines on Biosimilars
registration
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Draft Redaction Group
Our project has started since April 2015
first draft before 2016 :
UPM
NMCL
NCPV
Experts :
Clinicians
Analytical chemistry
Biotechnology
Pharmacology
Clinical trials
Pharmacovigilance
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Draft Redaction Group
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Draft Redaction Group
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Main sections of the Guideline
the same as most of the biosimilar guidelines
Scope
Registration procedure
Quality
Non-clinical evaluation
Clinical evaluation
Pharmacovigilance
Interchangeability
Transfert of technology
28 Legal basis
TUNISIAN GUIDELINES :
CHALLENGES
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First Challenge
Scope
Registration procedure
Quality
Non-clinical evaluation
Clinical evaluation
Pharmacovigilance
Interchangeability
Transfert of technology
Legal basis
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IMPORTED biosimilars registration procedure
COMBINED MAA
EVALUATION
Preclinical
Quality & Clinical M3 SUBMISSION M4+ M5 (EXPERTS)
assessment data
assessment
M3 ASSESSMENT(NMCL) SSC
32 MA
Challenges
Scope
Registration procedure
Quality
Non-clinical evaluation
Clinical evaluation
Pharmacovigilance
Interchangeability
Transfert of technology
Legal basis
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Challenges
Quality, preclinical and clinical issues :
The working group was splitted into 3 taskforces to
discuss the choice of the suitable guideline that would
be adopted in each section
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Challenges
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Challenges
Pharmacovigilance :
In Tunisia, we have already adopted a main part of the
Guideline on good pharmacovigilance practices (GVP) For
Arab Countries, since July 2015.
The interchangeability :
In Tunisia, we follow the “call for tenders” mode to
import most of the hospital drugs the medicine could
be substituted every one or 2 years.
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THE BIG Challenge
Scope
Registration procedure
Quality
Non-clinical evaluation
Clinical evaluation
Pharmacovigilance
Interchangeability
Transfer of technology
Legal basis
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THE BIG Challenge
In case of a transfer of technology : the most frequent case for
locally manufactured biosimilars in Tunisia
Local manufacturer has a partnership with a foreign referent
laboratory :
Same active substance
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A STEPWISE or A COMBINED APPROACH???
Transfer of technology
SSC - TC
Caractérisation Analyses
MA biologique
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PERSPECTIVES
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Perspectives
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Economic Benefit
Cost in MD of REMICADE vs biosimilar (at least -30%)
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1 M$
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5
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REMICADE
2
BIOSIMILAR
1
0
2012 2013 2014 estimation 2015
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"The courage of the water drop is
to fall into the desert." Lao She
Thank you !
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